AI-Enabled Clinical Development Tools

AI tools for every stage of clinical development — from synopsis to submission.

The platform that empowers drug developers with intelligent tools for protocol design, data management, statistical analysis, medical writing, and regulatory submission.

Standards & Frameworks Built In

ICH M11 ProtocolsSAP / ICH E9SDTM v3.4ADaM v1.3 Define-XML 2.1TFLsICH E3 (CSR) ICH E2F (DSUR)DSMB / DMCDECeCTD Investigator BrochureMedDRAWHO-DrugDataset-JSON E2B(R3)FAERS

How It Works

Design. Build. Submit.

AI tools that work the way clinical teams think — from study startup through regulatory filing.

Design Your Study

Generate ICH M11-compliant protocols, statistical analysis plans, investigator brochures, DSMB charters, and dose escalation committee plans from your study synopsis. AI drafts — you review and refine.

ProtocolsSAPsIBsDSMBDEC

Build Your Data Package

Upload raw clinical data from any EDC. Our AI agents automatically map, transform, and validate CDISC-compliant datasets, TFLs, and Define-XML.

SDTMADaMTFLsDefine-XML

Submit with Confidence

Generate clinical study reports, DSURs, and eCTD packages. Every output validated against 2,000+ rules and formatted for FDA, EMA, and PMDA.

CSRsDSURseCTD

Security

Enterprise-Grade Data Security

Your clinical data is protected by the highest standards of regulatory compliance.

21 CFR Part 11

Full compliance with FDA regulations for electronic records and signatures. Complete audit trails, validated systems, and secure access controls.

HIPAA Security Rule

PHI handled per 45 CFR §164.312 technical safeguards — AES-256 encryption, unique user identification, and integrity controls.

Secure Data Transfer

TLS 1.3 encrypted transmission, SFTP/HTTPS protocols, and end-to-end encryption. Data protected in transit and at rest.

ICH E6(R2) GCP

All data handling follows ICH Good Clinical Practice guidelines for data integrity and traceability.

What We Deliver

Comprehensive Clinical Study Management Tools

14 AI agents covering every document and dataset your study needs — from first-in-human through regulatory filing.

📝

Protocol Development

AI-generated ICH M11-compliant protocols from your study synopsis. Reduce amendments with built-in complexity scoring.

📐

Statistical Analysis Plans

Complete SAPs with endpoint definitions, analysis methods, multiplicity adjustments, and mock TFL shells.

📘

Investigator Brochures

AI-drafted IB sections per ICH M4 — nonclinical summaries, clinical pharmacology, safety data, and benefit-risk. Kept current as data matures.

🛡️

DSMB Charters

Data Safety Monitoring Board charters per FDA 2024 guidance. Interim analysis plans with alpha-spending boundaries and stopping rules.

⚗️

Dose Escalation Committees

DEC charters, dose-limiting toxicity rules, escalation/de-escalation schemas (3+3, mTPI, BOIN), and cohort review templates for Phase 1 studies.

📋

SDTM Specifications & Datasets

Complete mapping specs and submission-ready datasets compliant with IG v3.3/v3.4 and current controlled terminology.

📊

ADaM Specifications & Datasets

Full ADaM specs for ADSL, ADAE, ADLB, ADVS, ADTTE, and custom BDS datasets with complete derivation logic.

📑

Tables, Figures & Listings

Publication-quality TFLs for CSRs, safety reports, interim analyses, DSURs, and IBs. Standard and custom shells.

🗂️

Define-XML & Metadata

Submission-ready Define-XML 2.1 metadata files with complete variable, codelist, and method documentation.

📄

Clinical Study Reports

AI-generated ICH E3 clinical study reports with drug, device, and diagnostic modules. Full narrative, safety, and efficacy — 40% faster.

🧬

MedDRA & WHO-Drug Coding

Medical dictionary coding of adverse events and medications with version-controlled mapping and full audit trail.

⚠️

Safety Reporting & DSURs

Development Safety Update Reports per ICH E2F. ICSRs, aggregate safety analyses, and signal detection.

🔍

Validation & Auto-Fix

2,000+ conformance rules with AI-powered auto-remediation. Fix issues before submission — not after rejection.

📦

eCTD & Regulatory Publishing

Module 5 clinical data assembly, sequence publishing, and gateway submission for FDA, EMA, PMDA, and Health Canada.

🔬 InterClin Ai Validate

Built-in conformance validation that doesn't just find errors — it fixes them automatically. Learn more →

Conformance Checking

Validates SDTM and ADaM datasets against CDISC rules, FDA Business Rules, and controlled terminology — instantly.

Auto-Fix Engine

Unlike other validators, InterClin Ai Validate identifies issues AND generates corrected datasets with a single click.

Submission Readiness

Full pre-submission QC report covering P21 rules, OpenCDISC checks, and FDA Technical Conformance Guide compliance.

Platform

One Platform for the Entire Clinical Study Lifecycle

From study design through regulatory submission — AI tools that replace fragmented workflows with a unified platform.

Study Design & Planning

AI-generated protocols, statistical analysis plans, investigator brochures, DSMB charters, and dose escalation committee plans. Reduce protocol amendments, accelerate study startup, and align teams from day one.

Clinical Data Management

Automated SDTM and ADaM dataset creation from raw EDC exports. Intelligent data mapping, transformation, and CDISC compliance — without SAS programmers.

Statistical Analysis & TFLs

Publication-quality tables, figures, and listings for CSRs, interim analyses, DSURs, and IBs. Standard and custom shells generated from your SAP.

Medical Writing & Reporting

AI-powered clinical study reports (ICH E3), DSURs (ICH E2F), investigator brochures, safety narratives, and regulatory response documents — drafted in hours, not weeks.

Safety & Oversight Committees

DSMB charters, DEC escalation schemas, MedDRA and WHO-Drug coding, signal detection, aggregate safety analyses, and interim analysis outputs with unblinded safety summaries.

Regulatory Submission

Define-XML metadata, ADRG/SDRG documents, validation with auto-fix, eCTD assembly, and electronic gateway submission for FDA, EMA, PMDA, and Health Canada.

Ready to transform your clinical development?

See our plans or launch the platform to start managing your clinical studies with AI.

🔒 HIPAA🔒 21 CFR Part 11🔒 AES-256🔒 ICH E6(R2)

Build the future of clinical development

We're assembling a small, senior team to transform how drugs get to market. If you've spent your career in clinical research and want to build something that changes the industry — we want to talk.

InterClin Ai is building the AI-enabled clinical development platform — replacing fragmented workflows across biometrics, medical writing, regulatory affairs, and safety operations with 14 intelligent AI agents. We're looking for experienced professionals who've been in the trenches — people who've led submissions, built clinical programs, closed enterprise deals, and shipped production software. This is a ground-floor opportunity with a company positioned to disrupt the $85B+ clinical development market.

Senior-Level Team Remote-First Equity Compensation Pharma / Biotech Experience Required

Vice President, Business Development

Critical First Hire Remote Full-Time Equity + Salary

Own the revenue engine. You have 10+ years selling data services, SaaS, or CRO solutions to pharma/biotech — and a network of VP-level contacts in biometrics, clinical operations, and regulatory affairs.

Why This Role Matters

This is the most important hire we make. You will be the primary revenue driver — identifying, qualifying, and closing enterprise clients.
InterClin Ai's technology is built. What we need is someone who can put it in front of the right decision-makers and articulate why an AI-enabled clinical development platform at a fraction of CRO cost is a strategic advantage.

Responsibilities

Build and execute go-to-market strategy targeting pharma, biotech, and medical device companies
Develop and manage enterprise sales pipeline from prospecting through close
Lead client presentations and product demonstrations to senior biostatistics, regulatory, and operations leadership
Negotiate contracts, MSAs, and SOWs for engagements ranging from $100K to $1M+ annually
Represent InterClin Ai at industry conferences (DIA, PHUSE, PharmaSUG, CDISC Interchange)
Provide market intelligence to shape product roadmap and pricing strategy

Requirements

10+ years in business development, sales, or partnerships within clinical data, CRO, or life sciences SaaS
Established network of decision-makers at pharma/biotech companies (VP Biometrics, Head of Regulatory, Head of Clinical Operations)
Track record of closing $500K+ enterprise deals in regulated life sciences
Deep understanding of the CDISC standards ecosystem and regulatory submission process
Experience selling to both small biotech (5-50 people) and large pharma (1,000+)
Comfortable operating in a startup environment — building processes from zero

Director, Regulatory Strategy

Critical First Hire Remote Full-Time Equity + Salary

You've been on the other side — a former FDA statistical reviewer, or you've led 10+ NDA/BLA/MAA submissions end to end. You give InterClin Ai the regulatory credibility that wins enterprise trust.

Why This Role Matters

Pharma companies won't trust their submission data to a platform without a credible regulatory voice. You are that voice.
You ensure every output InterClin Ai generates meets the exact expectations of FDA, EMA, PMDA, and NMPA reviewers — because you've been the reviewer, or you've sat across the table from them.

Responsibilities

Serve as the regulatory authority and external-facing subject matter expert for all client engagements
Validate Ai-generated outputs against FDA Study Data Technical Conformance Guide, ICH guidelines, and regional requirements
Develop quality assurance frameworks and SOPs for InterClin Ai deliverables
Author and review SDRGs, ADRGs, and regulatory response documents
Advise on FDA, EMA, PMDA, and NMPA submission data expectations across therapeutic areas
Participate in client pitches and due diligence calls as the regulatory credibility anchor

Requirements

15+ years in regulatory affairs, biostatistics, or clinical data management within pharma, CRO, or FDA
Direct experience with 10+ NDA, BLA, MAA, or JNDA submissions
Former FDA statistical reviewer or CDER/CBER experience strongly preferred
Expert knowledge of CDISC standards (SDTM, ADaM, Define-XML) and FDA Technical Conformance Guide
Experience interfacing with FDA review divisions, including pre-submission meetings and information requests
Strong written and verbal communication — you'll represent InterClin Ai to C-suite and regulatory leadership

Senior CDISC Standards Lead

Critical First Hire Remote Full-Time Equity + Salary

The person who makes sure every variable, codelist, and derivation is bulletproof. You've implemented CDISC standards at 5+ companies and can spot a conformance issue before Pinnacle 21 does.

Why This Role Matters

You are the quality layer between Ai output and client delivery. Every SDTM mapping, every ADaM derivation, every Define-XML metadata file passes through your expert review.
You also build the rule engine behind InterClin Ai Validate — defining the conformance checks, remediation logic, and controlled terminology mappings that make our validator superior to Pinnacle 21.

Responsibilities

QC and validate all Ai-generated SDTM and ADaM specifications, datasets, and metadata
Design and maintain the CDISC conformance rule library for InterClin Ai Validate
Implement controlled terminology updates within days of CDISC releases
Define mapping conventions, derivation standards, and trial design patterns across therapeutic areas
Train and refine the Ai engine's CDISC prompt library for maximum output accuracy
Serve as the CDISC subject matter expert for client-facing technical discussions

Requirements

10+ years as a CDISC standards programmer, standards manager, or data standards lead
Deep expertise in SDTM IG (v3.3/3.4), ADaM IG (v1.1/1.3), Define-XML 2.1, and current controlled terminology
Implemented CDISC standards programs at 5+ pharmaceutical or CRO organizations
Extensive experience with Pinnacle 21 (Community and Enterprise) validation and issue resolution
Proficiency in SAS and/or Python for data manipulation and specification generation
CDISC certification (SDTM and/or ADaM) strongly preferred

Director, Drug Safety & Pharmacovigilance

Critical First Hire Remote Full-Time Equity + Salary

You've managed safety databases, authored DSURs and PBRERs, and submitted thousands of ICSRs to FAERS and EudraVigilance. You own everything pharmacovigilance at InterClin Ai — from signal detection to regulatory reporting.

Why This Role Matters

Safety reporting has zero margin for error and hard regulatory deadlines — 15-day expedited ICSRs, annual DSURs, quarterly PADERs. You ensure InterClin Ai meets every one of them.
As we expand beyond CDISC submissions into pharmacovigilance services, you are the domain authority who builds our safety reporting capabilities, trains the Ai models on PV workflows, and gives clients confidence that their safety obligations are handled by an expert.

Responsibilities

Lead all pharmacovigilance and drug safety operations across client engagements
Author and review DSURs (ICH E2F), PBRERs/PSURs (ICH E2C), and PADERs for client submissions
Manage ICSR processing, quality review, and expedited reporting to FDA FAERS, EMA EudraVigilance, and PMDA
Oversee MedDRA and WHO-Drug coding operations and version migration
Conduct signal detection, benefit-risk evaluations, and aggregate safety analyses
Define safety database configuration and workflows (Argus, ArisG, or equivalent)
Build and refine Ai-powered safety reporting templates and automation workflows
Serve as the pharmacovigilance subject matter expert for client-facing discussions and audits

Requirements

12+ years in drug safety, pharmacovigilance, or safety reporting within pharma, biotech, or CRO
Extensive experience with Oracle Argus Safety, ArisG, or equivalent safety database platforms
Authored 10+ DSURs and/or PBRERs across multiple therapeutic areas
Deep expertise in E2B(R3) ICSR format, FAERS electronic submission, and EudraVigilance reporting
Strong knowledge of 21 CFR 312.32, 314.80, ICH E2F, ICH E2C(R2), and CIOMS reporting standards
Experience with signal detection methodologies and benefit-risk assessment frameworks
MedDRA and WHO-Drug coding expertise with version-controlled mapping experience
Qualified Person for Pharmacovigilance (QPPV) certification or eligibility preferred

Head of Client Success

Remote Full-Time Equity + Salary

You've managed 50+ clinical studies at a CRO or pharma company and know exactly what delivery excellence looks like. You own the client relationship from contract to renewal.

Responsibilities

Own end-to-end client relationships from onboarding through renewal
Manage project timelines, deliverable tracking, and quality checkpoints for each engagement
Serve as the primary point of contact for client biometrics and data management teams
Coordinate between client data teams and InterClin Ai's CDISC and regulatory leads
Track client satisfaction metrics and identify upsell opportunities (additional studies, deliverables)
Develop onboarding workflows, client-facing documentation, and training materials

Requirements

8+ years in project management, client services, or delivery at a CRO, pharma, or clinical data SaaS company
Managed 50+ clinical studies across multiple therapeutic areas and phases
Experience with CDISC data deliverables (SDTM, ADaM, TFLs, Define-XML)
Exceptional communication skills — comfortable managing relationships with VP-level biostatistics and regulatory stakeholders
PMP or equivalent project management certification preferred

Senior Full-Stack Engineer

Remote Full-Time Equity + Salary

You build production systems that handle sensitive data in regulated environments. Python, AWS, and a security-first mindset. You'll take our working prototype and make it enterprise-ready.

Responsibilities

Deploy and scale the InterClin Ai platform on AWS (Lambda, ECS, API Gateway, S3, RDS)
Build secure file handling for clinical data uploads and deliverable downloads
Implement authentication, role-based access, and audit logging per 21 CFR Part 11 requirements
Integrate the Claude API engine with the client-facing web application
Build billing, subscription management, and usage tracking
Implement HIPAA-compliant infrastructure with encryption at rest and in transit

Requirements

7+ years in full-stack engineering with Python backend (Flask/Django/FastAPI)
Deep AWS experience — Lambda, ECS, API Gateway, S3, RDS, Cognito, CloudTrail, KMS
Experience building applications in regulated environments (HIPAA, GxP, SOC 2, 21 CFR Part 11)
Proficiency with modern frontend (React, TypeScript) and responsive design
Experience integrating LLM/Ai APIs in production (OpenAI, Anthropic, or equivalent)
Strong security mindset — encryption, access controls, audit trails, penetration testing

Head of Marketing

Remote Full-Time Equity + Salary

You build pipeline through content, not cold calls. Whitepapers, case studies, conference presence, LinkedIn thought leadership — you fill the top of the funnel so BD can close.

Responsibilities

Develop and execute go-to-market content strategy targeting biostatistics, data management, and regulatory decision-makers
Create compelling content: whitepapers, case studies, blog posts, product demos, and LinkedIn campaigns
Manage InterClin Ai's presence at industry conferences (DIA, PHUSE, PharmaSUG, CDISC Interchange)
Build and manage the company website, SEO strategy, and paid acquisition channels
Develop product positioning and competitive messaging (especially vs. CROs and Pinnacle 21)
Track marketing-qualified leads and attribution metrics across all channels

Requirements

8+ years in B2B marketing within life sciences, health tech, or clinical data SaaS
Experience marketing to pharma/biotech audiences (biometrics, regulatory, clinical operations)
Strong writing skills — able to translate technical capabilities into business value
Experience with content marketing, demand generation, and account-based marketing
Familiarity with CDISC, FDA submission processes, or CRO services preferred
Comfortable as a solo marketer building from zero with a small budget

Clinical Data Analyst

Remote Full-Time Salary

You're early in your career but already have hands-on experience with SDTM/ADaM datasets. You handle day-to-day data processing, client data ingestion, and output QC alongside our CDISC Standards Lead.

Responsibilities

QC Ai-generated SDTM and ADaM specifications against source data and protocol requirements
Process and ingest client raw data files, eCRF exports, and lab data feeds
Run Pinnacle 21 and InterClin Ai Validate checks and document findings
Maintain controlled terminology mappings and codelist libraries
Support the CDISC Standards Lead in building and refining specification templates
Document standard operating procedures and data conventions

Requirements

2-5 years in clinical data management, statistical programming, or CDISC standards
Working knowledge of SDTM and ADaM structures, Define-XML, and controlled terminology
Proficiency in SAS and/or Python for data manipulation
Experience with Pinnacle 21 validation
Detail-oriented with strong documentation skills
BS/MS in Biostatistics, Computer Science, Data Science, or related field

Contract Opportunities

Project-based roles for experienced professionals. Flexible engagement.

SAS / Python Statistical Programmer

Contract Remote Per-Study Engagement

Experienced statistical programmers who can QC and validate Ai-generated outputs, run double programming, and ensure submission-ready quality on a per-study basis.

Scope of Work

Independent QC of Ai-generated SDTM and ADaM datasets against raw data and specifications
Double programming of key TFL outputs per SAP requirements
Pinnacle 21 validation execution and issue resolution documentation
Define-XML generation and metadata validation
Macro development and refinement for recurring deliverables

Requirements

5+ years as a SAS and/or Python statistical programmer in pharma, biotech, or CRO
Extensive experience creating SDTM and ADaM datasets for regulatory submissions
Proficiency with Pinnacle 21 validation and issue resolution
Experience with Phase 1-3 oncology, immunology, or CNS studies preferred
Available for 10-40 hours/week depending on study workload

Medical Writer

Contract Remote Per-Project

You've authored SDRGs, ADRGs, CSR sections, and regulatory response documents. We need your expertise to polish Ai-generated drafts into submission-ready prose.

Scope of Work

Review and refine Ai-generated SDRG and ADRG documents
Author CSR sections (Section 11, 14, 16) incorporating TFL outputs
Prepare regulatory response documents and information request replies
Develop templates for recurring document types
Ensure compliance with ICH E3, FDA guidance, and company standards

Requirements

5+ years in medical or regulatory writing for pharma, biotech, or CRO
Experience authoring SDRGs, ADRGs, and CSR statistical sections
Familiarity with CDISC data structures and how they relate to submission documents
Strong attention to detail and ability to meet regulatory submission timelines
RAC or AMWA certification preferred

Cybersecurity & Compliance Consultant

Contract Remote Engagement-Based

Set up and audit our security and compliance infrastructure — HIPAA, SOC 2, 21 CFR Part 11 — so enterprise clients trust us with their clinical data.

Scope of Work

Design and implement HIPAA-compliant infrastructure architecture on AWS
Develop security policies, access controls, and audit trail requirements per 21 CFR Part 11
Conduct initial security assessment and penetration testing
Prepare SOC 2 Type I/II readiness documentation
Establish data encryption standards (at rest and in transit) and key management procedures
Quarterly security reviews and compliance audits

Requirements

8+ years in cybersecurity, compliance, or information security
Experience with HIPAA, SOC 2, 21 CFR Part 11, and GxP regulations
Deep AWS security expertise (IAM, KMS, CloudTrail, GuardDuty, Config)
Experience securing health tech or life sciences SaaS platforms
CISSP, CISM, or equivalent certification

UX/UI Designer

Contract Remote Project-Based

Design the client-facing platform experience — from data upload to deliverable download. You make complex biostatistics workflows feel intuitive and polished.

Scope of Work

Design the complete InterClin Ai platform UI — workspace, file upload, deliverable management, validation dashboard
Create high-fidelity mockups and interactive prototypes in Figma
Develop a component library and design system aligned with InterClin Ai branding
Conduct user research with biostatisticians and data managers to validate workflows
Deliver production-ready specifications for frontend engineering handoff

Requirements

5+ years in product design for B2B SaaS, data platforms, or enterprise tools
Strong portfolio demonstrating complex workflow design and data-heavy interfaces
Proficiency in Figma and modern prototyping tools
Experience designing for regulated or healthcare environments preferred
Understanding of accessibility standards and responsive design

Don't see your role?

We're always looking for exceptional people with clinical data, regulatory, or Ai experience. Send your resume to careers at interclinai.com.

🔒 HIPAA🔒 21 CFR Part 11🔒 AES-256🔒 ICH E6(R2)

Validate

Conformance checking that goes beyond reporting.

The industry's first Ai-powered clinical data validator. Part of the InterClin Ai clinical development platform — identify conformance issues across your SDTM, ADaM, and Define-XML, then automatically remediate them before submission.

SDTM Conformance ADaM Conformance Define-XML FDA Business Rules PMDA Rules SEND

Side-by-Side

How we compare to Pinnacle 21

Pinnacle 21 by Certara is the industry standard — the same validation software used internally by the FDA and PMDA to screen submissions. InterClin Ai Validate implements the same conformance rules and goes further.

Capability	Pinnacle 21 by Certara	InterClin Ai Validate Ai-POWERED
Automatic Error Remediation Fix conformance issues — not just report them	✗	✓
Context-Aware Corrections Understands your protocol, CRF, and mapping logic to make intelligent fixes	✗	✓
Corrected Dataset Output Download remediated datasets alongside your validation report	✗	✓
Natural Language Explanations Plain-English descriptions of issues and resolutions	✗	✓
SDRG / ADRG Text Generation Auto-generate Reviewer's Guide text for issues requiring documentation	✗	✓
Included with Platform No separate per-seat licensing required	✗	✓
SDTM Conformance Validation Check datasets against SDTM IG rules and CDISC CT	✓	✓
ADaM Conformance Validation Check datasets against ADaM IG rules	✓	✓
Define-XML Validation Validate metadata completeness and compliance	✓	✓
SEND Validation Nonclinical data conformance checking	✓	✓
FDA Business Rules FDA-published validation rules for submission data	✓	✓
PMDA Validation Rules Japan regulatory conformance checking	✓	✓
Used by FDA / PMDA Internally Same tool regulators use to screen your submission	✓	—
CLI and API Access Command line and programmatic automation	✓	✓
Dataset-JSON Support Next-generation CDISC transport format	✓	✓

How It Works

Upload. Validate. Fix. Submit.

A single pass replaces the validate-fix-revalidate cycle that typically takes days.

📤

Upload Datasets

Drag and drop your SDTM or ADaM datasets — SAS transport (.xpt), CSV, or Dataset-JSON. Include your Define-XML for full metadata validation.

🔍

Conformance Scan

Validates against 2,000+ CDISC conformance rules, FDA Business Rules, and current controlled terminology. Seconds, not minutes.

🔧

Ai Auto-Fix

Each issue is analyzed in the context of your study design, mapping specifications, and protocol. Corrections are generated automatically.

📊

Detailed Report

Every finding documented — what was wrong, what was fixed, and what requires human review. Export to Excel or PDF.

📥

Clean Datasets

Download corrected datasets alongside originals. Full audit trail of every change for 21 CFR Part 11 compliance.

📝

Reviewer's Guide Text

For issues that can't be fixed programmatically, auto-generate the explanation text for your SDRG or ADRG.

Live Preview

See it in action

Processing an SDTM package with automatic remediation.

interclin validate — NVT-101-001/sdtm

$ interclin validate ./sdtm/ --auto-fix --define=define.xml

✓ Loaded 18 SDTM datasets (DM, AE, CM, DS, EX, LB, VS, MH, RS, TU, TR...)
✓ Loaded Define-XML 2.1 metadata
✓ Rule engine: SDTM IG v3.4 · FDA Business Rules · CT 2025-09-26

─────────────────────────────────────────────────────
ERROR SD1020 AE.AESTDTC — 3 values with non-ISO 8601 format
  → FIXED: Converted "2025/03/15" to "2025-03-15" (3 records)

ERROR SD0027 DM.ARMCD — Value "TRT1" not in controlled terminology
  → FIXED: Mapped to "NVT3087" per TA domain definition

WARN SD1117 LB.LBORNRLO — Missing normal ranges for 47 records
  → FIXED: Populated from lab vendor reference ranges by LBTESTCD

WARN SD0084 VS.VSBLFL — Baseline flag not derived for 12 subjects
  → FIXED: Applied LOBXFL algorithm (last non-null before RFSTDTC)

NOTE   SD1274 TS.TSVAL — ACTSUB populated as null (expected pre-lock)
  → SKIPPED: Requires manual entry. Text added to SDRG draft.

─────────────────────────────────────────────────────

COMPLETE 2,847 rules · 5 findings · 4 auto-fixed · 1 documented
✓ Corrected datasets → ./sdtm-validated/
✓ Validation report → ./NVT-101-001_validation_report.xlsx
✓ SDRG draft text    → ./NVT-101-001_sdrg_issues.docx
Completed in 34 seconds.

Coverage

Comprehensive rule coverage, always current

Every CDISC release, every FDA update — reflected within days, not months.

2,000+

CDISC Conformance Rules

400+

FDA Business Rules

46K+

Controlled Terms

90%+

Auto-Fix Rate

Stop fixing. Start submitting.

InterClin Ai Validate is included with every InterClin Ai plan. No separate licensing.

🔒 HIPAA🔒 21 CFR Part 11🔒 AES-256🔒 ICH E6(R2)